Background
Methods
Study design and patient selection
Pre-treatment evaluation, planning, inclusion/exclusion criteria, and 90Y therapy
Clinical follow-up and health-related quality of life assessment
Statistical analysis
Results
Overall baseline characteristics
Patient Characteristics | Parameters | Overall n (%) | 1 month PCS within 2SD of NBS (n = 18) | 1 month PCS > 2SD below NBS (n = 12) | p-value | |
---|---|---|---|---|---|---|
Age | Median (range) | 62 (35–82) | 60.8 | 61.3 | 0.46 | |
Gender | Male | 23 (77%) | 13 | 10 | 0.31 | |
Female | 7 (23%) | 5 | 2 | |||
Ethnicity | White | 24 (80%) | 14 | 10 | 0.37 | |
Black | 4 (13%) | 3 | 1 | |||
Other | 2 (7%) | 1 | 1 | |||
HCC Etiology | HCV | 16 (53%) | 10 | 6 | 0.42 | |
HBV | 2 (7%) | 1 | 1 | |||
ALD | 5 (17%) | 3 | 2 | |||
Other causes of cirrhosis | 7 (23%) | 4 | 3 | |||
Non-Liver Comorbidities (e.g. Hypertension, Diabetes) | Present | 22 (73%) | 14 | 8 | 0.25 | |
Absent | 8 (27%) | 4 | 4 | |||
Portal Hypertension | Present | 20 (67%) | 11 | 9 | 0.43 | |
Absent | 10 (33%) | 7 | 3 | |||
Hepatic Encephalopathy | Present | 3 (10%) | 1 | 2 | 0.33 | |
Absent | 27 (90%) | 17 | 10 | |||
Child-Pugh Class | A | 20 (67%) | 11 | 9 | 0.19 | |
B | 10 (33%) | 7 | 3 | |||
C | 0 (0%) | 0 | 0 | |||
ECOG Performance Status | 0 | 13 (43%) | 9 | 4 | 0.17 | |
1 | 17 (57%) | 9 | 8 | |||
Tumor Morphology | Tumor Locations | Unilobar | 19 (63%) | 12 | 7 | 0.82 |
Bilobar | 11 (37%) | 6 | 5 | |||
Number of Nodules | Solitary | 11 (37%) | 7 | 4 | 0.23 | |
Multiple | 19 (63%) | 11 | 8 | |||
Mean largest tumor size (cm) |
9.2 (4.9–19)
|
9.7
|
9.1
|
0.04
| ||
Mean largest tumor volume (cm3) | 588 (145–1136) | 580 | 602 | 0.42 | ||
Tumor Burden | <50% | 20 (67%) | 11 | 9 | 0.20 | |
50%–75% | 10 (33%) | 7 | 3 | |||
>75% | 0 (0%) | 0 | 0 | |||
Portal Vein Thrombosis (PVT) | Presence | Present | 30 (100%) | 18 | 12 | 0.26 |
Absent | 0 (0%) | 0 | 0 | |||
Location | Main PV | 6 (20%) | 4 | 2 | 0.63 | |
Branch PV | 24 (80%) | 14 | 10 | |||
Degree of Occlusion | Occlusive | 23 (77%) | 13 | 10 | 0.30 | |
Non-Occlusive | 7 (23%) | 5 | 2 | |||
Laboratory Data | Mean Serum AFP (ng/dl) | 715 (3.3 to >2400) | 703 | 801 | 0.36 | |
Previous Treatment | No | 10 (33%) | 7 | 3 | 0.22 | |
Yes | 20 (67%) | 11 | 9 | |||
Type of Previous Treatmenta | cTACE/DEB-TACE | 14 (47%) | 10 | 4 | 0.19 | |
RFA | 0 (0%) | 0 | 0 | |||
Liver Resection | 0 (0%) | 0 | 0 | |||
Sorafeniba | 6 (20%) | 4 | 2 | |||
Lung Shunt Fraction (LSF) | Mean (%) | 11.0 (5.1–19.8) | 11.3 | 10.8 | 0.52 |
SF-36 survey results
HRQOL analysis
90Y Radioembolization and physical component summary scores
Survival and outcomes
Prognostic Factor | Parameters Compared | Overall Survival (OS) | Time to Progression (TTP) | ||||||
---|---|---|---|---|---|---|---|---|---|
Univariate Analysis | Multivariate Analysis | Univariate Analysis | Multivariate Analysis | ||||||
HR (95% CI) | p-value | HR (95% CI) | p-value | HR (95% CI) | p-value | HR (95% CI) | p-value | ||
Age | >65 vs. ≤65 years | 1.13 (0.44–2.94) | 0.12 | N/A | – | 1.14 (0.44–2.95) | 0.80 | N/A | – |
Gender | Male vs. Female | 1.28 (0.41–3.98) | 0.67 | N/A | – | 1.19 (0.39–3.66) | 0.76 | N/A | – |
Comorbidity | Present vs. Absent | 0.80 (0.26–2.45) | 0.69 | N/A | – | 0.98 (0.32–3.00) | 0.97 | N/A | – |
Portal Vein Thrombosis | Main vs. Branch Portal Vein | 1.70 (0.55–5.25) | 0.36 | N/A | – | 1.68 (0.55–5.17) | 0.37 | N/A | – |
Occlusive vs. non-occlusive | 1.23 (0.39–3.82) | 0.72 | N/A | – | 1.19 (0.39–3.66) | 0.76 | N/A | – | |
Tumor Size | >10 vs. ≤10 cm | 1.02 (0.39–2.65) | 0.97 | N/A | – | 0.89 (0.34–2.31) | 0.81 | N/A | – |
Tumor Volume | >500 vs. ≤500 cm3 | 1.34 (0.48–3.43) | 0.87 | N/A | – | 1.12 (0.73–3.15) | 0.72 | N/A | – |
Tumor Extent | Unilobar vs. Bilobar | 1.02 (0.38–2.77) | 0.96 | N/A | – | 1.08 (0.40–2.93) | 0.88 | N/A | – |
Solitary vs. Multifocal | 1.43 (0.61–4.15) | 0.76 | N/A | – | 1.12 (0.43–2.17) | 0.69 | N/A | – | |
Portal Hypertension | Present vs. Absent | 2.69 (0.77–9.40) | 0.12 | N/A | – | 2.53 (0.73–8.80) | 0.146 | N/A | – |
Encephalopathy | Present vs. Absent | 1.45 (0.33–6.44) | 0.62 | N/A | – | 1.38 (0.31–6.05) | 1.38 | N/A | – |
ECOG PS | 0 vs. 1–2 |
16.17 (2.06–126.83)
|
0.018
|
11.29 (1.92–19.06)
|
0.021
|
13.01 (1.69–100.4)
|
0.016
|
13.52 (1.65–175.27)
|
0.004
|
Child Pugh Class | A vs. B |
8.21 (2.59–26.04)
|
0.006
|
6.32 (1.79–16.55)
|
0.013
|
7.07 (2.17–23.00)
|
0.009
|
12.31 (2.58–59.23)
|
0.005
|
Alpha-fetoprotein | >400 vs. ≤400 ng/dl | 1.12 (0.43–2.97) | 0.82 | N/A | – | 1.06 (0.40–2.78) | 0.911 | N/A | – |
Lung Shunt Fraction | >10% vs. ≤10% |
4.89 (1.55–15.63)
|
0.004
|
6.42 (1.96–10.31)
|
0.029
|
3.91 (1.33–11.36)
|
0.013
|
7.91 (3.06–17.48)
|
0.011
|
Treatments prior to Y-90 | Yes vs. No | 1.67 (0.37–3.18) | 0.35 | N/A | – | 1.74 (0.51–2.93) | 0.41 | N/A | – |
Baseline MCS | Within 2SD vs. >2SD below of NBS | 1.25 (0.22–2.57) | 0.38 | N/A | – | 1.18 (0.77–3.68) | 0.36 | N/A | – |
Baseline PCS | Within 2SD vs. >2SD below of NBS | 1.38 (0.66–3.39) | 0.58 | N/A | – | 1.29 (0.93–3.17) | 0.19 | N/A | – |
MCS at 1 month post-Y90 | Within 2SD vs. >2SD below of NBS | 2.24 (0.98–3.98) | 0.17 | N/A | – | 2.13 (0.53–3.66) | 0.83 | N/A | – |
PCS at 1 month post-Y90 | Within 2SD vs. >2SD below of NBS |
2.59 (1.04–4.23)
|
0.026
|
1.73 (1.02–3.18)
|
0.041
|
2.03 (1.13–4.57)
|
0.023
|
3.28 (1.48–5.13)
|
0.044
|
MCS at 3-months post-Y90 | Within 2SD vs. >2SD below of NBS | 1.87 (0.49–2.13) | 0.83 | N/A | – | 1.55 (0.90–2.98) | 0.88 | N/A | – |
PCS at 3 months post-Y90 | Within 2SD vs. >2SD below of NBS | 1.48 (0.86–3.02) | 0.44 | N/A | – | 1.47 (0.74–2.93) | 0.59 | N/A | – |
MCS at 6 months post-Y90 | Within 2SD vs. >2SD below of NBS | 1.44 (0.82–2.73) | 0.23 | N/A | – | 1.96 (0.42–4.13) | 0.38 | N/A | – |
PCS at 6-months post-Y90 | Within 2SD vs. >2SD below of NBS | 1.59 (0.92–2.11) | 0.71 | N/A | – | 1.37 (0.79–3.13) | 0.62 | N/A | – |